MAUDE Adverse Event Report: SHANDONG WEIGAO GROUP MEDICAL POLYMER CO., LTD NIPRO SYRINGE WITH NEEDLE

Model Number JD+10L2025-WEI

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/24/2019

Event Type  Injury  

Event Description

Syringe tip broke off in the venous portion of the permanent dialysis catheter while being prepped for treatment.The staff was unable to remove the syringe tip and the patient was sent to the emergency room for removal and replacement of the permanent dialysis catheter.No further information was provided.

• Brand Name: NIPRO SYRINGE WITH NEEDLE
• Type of Device: SYRINGE WITH NEEDLE
• Manufacturer (Section D): SHANDONG WEIGAO GROUP MEDICAL POLYMER CO., LTD; 20 xingshan road; address2 hight tech industrial; 267-2 019; CH 267-2019
• MDR Report Key: 9569361
• MDR Text Key: 174331031
• Report Number: 1056186-2019-00022
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 40383790001012
• UDI-Public: 40383790001012
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JD+10L2025-WEI
• Device Lot Number: 20190610
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/09/2020
• Distributor Facility Aware Date: 12/09/2019
• Device Age: 5 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention